[이코노믹리뷰=황진중 기자] Bridge Biotherapeutics (288330), a research and development company for innovative new drugs, announced on the 7th that it was administered for patients who participated in the clinical trial on the 2nd as the phase 1/2 clinical trial of BBT-176, a candidate for next-generation lung cancer target anticancer drug, began in earnest.
BBT-176 is a novel epidermal growth factor receptor tyrosine kinase inhibitor that targets the C797S-specific EGFR mutation.
The C797S mutation is known as an acquired resistance mutation that appears after treatment such as’tagriso (ingredient name osimertinib)’ in non-small cell lung cancer (NSCLC‧Non-small Cell Lung Cancer).
Bridge Biotherapeutics has secured data on the tumor suppression effect of brain metastasis, including the tumor suppression effect against the C797S positive triple mutation in animal models, through the preclinical development previously advanced.
This clinical trial, which is first initiated by three domestic institutions, is conducted in patients with locally advanced or metastatic NSCLC with EGFR mutations.
Bridge Biotherapeutics plans to closely grasp patient group data by mutation by applying a Liquid Biopsy procedure that more quickly analyzes mutation information in tumor cells through tumor genes in the blood.
BBT-176 In the first phase of clinical phase 1/2, the Dose Escalation Study evaluates the safety and tolerability of the drug to be tested to determine the recommended phase 2 dose.
In the Dose Expansion Study, which is expected to enter Korea and the U.S. within this year, ▲Objective Response Rate (ORR‧Objective Response Rate) according to version 1.1 of the Solid Tumor Response Evaluation Criteria (RECIST), ▲Reaction Duration (DoR‧Duration) of Response) and ▲ Progress-free Survival (PFS‧Progress-free Survival), etc., to examine the antitumor activity of BBT-176 in the selected mutant types. The clinical trial is planned to be conducted on about 90 patients.
Lee Jeong-gyu, CEO of Bridge Biotherapeutics, said, “I think it is meaningful to be the first to start clinical trials of BBT-176, a new anticancer drug candidate targeting C797S mutant NSCLC, which has no treatment options worldwide. We will accelerate business development so that we can seek global licensing opportunities by doing our best to ensure that clinical trials are conducted with full accuracy and swiftness based on the development process.” Said.
More detailed information related to the BBT-176 clinical trial, which was launched this time, can be found in the Clinical Trial Information menu of the Integrated Drug Information System of the Ministry of Food and Drug Safety.
On the other hand, Bridge Biotherapeutics, which started to discover its own candidates this year, started to discover and develop new candidates for NSCLC treatments that can effectively meet various unmet medical demands, including C797S double mutation.